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Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation

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ClinicalTrials.gov Identifier: NCT00924612
Recruitment Status : Completed
First Posted : June 19, 2009
Last Update Posted : August 27, 2010
Sponsor:
Information provided by:
Clarus Therapeutics, Inc.

Brief Summary:
The purpose of the study is to determine the effect of food with various amounts of fat on the absorption of an oral testosterone undecanoate formulation.

Condition or disease Intervention/treatment Phase
Male Hypogonadism Drug: Oral testosterone undecanoate (containing 300 mg of T) Phase 2

Detailed Description:
Pharmacokinetics will be evaluated after the following types of meals: very low fat, low fat, normal diet, high fat, and fasting. Subjects will have one dose of TU administered 30 minutes after the initiation of the meal.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of the Effect of Food With Various Levels of Fat on the Pharmacokinetics of an Oral Testosterone Undecanoate Formulation in Hypogonadal Men
Study Start Date : July 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : July 2010


Arm Intervention/treatment
Experimental: Fasting Drug: Oral testosterone undecanoate (containing 300 mg of T)
Single dose administered orally, 30 minutes after the initiation of protocol-defined breakfast or while fasting, in each of the 5 arms.
Experimental: Very low fat diet Drug: Oral testosterone undecanoate (containing 300 mg of T)
Single dose administered orally, 30 minutes after the initiation of protocol-defined breakfast or while fasting, in each of the 5 arms.
Experimental: Low fat diet Drug: Oral testosterone undecanoate (containing 300 mg of T)
Single dose administered orally, 30 minutes after the initiation of protocol-defined breakfast or while fasting, in each of the 5 arms.
Experimental: Normal diet Drug: Oral testosterone undecanoate (containing 300 mg of T)
Single dose administered orally, 30 minutes after the initiation of protocol-defined breakfast or while fasting, in each of the 5 arms.
Experimental: High fat diet Drug: Oral testosterone undecanoate (containing 300 mg of T)
Single dose administered orally, 30 minutes after the initiation of protocol-defined breakfast or while fasting, in each of the 5 arms.



Primary Outcome Measures :
  1. Serum testosterone Cmax [ Time Frame: 24-hour serial sampling following each of the treatment arms ]
  2. Serum testosterone Cavg [ Time Frame: 24-hour serial sampling following each of the treatment arms ]
  3. Serum testosterone Tmax [ Time Frame: 24-hour serial sampling following each of the treatment arms ]
  4. Serum testosterone AUC [ Time Frame: 24-hour serial sampling following each of the treatment arms ]

Secondary Outcome Measures :
  1. Serum DHT Cmax [ Time Frame: 24-hour serial sampling following each of the treatment arms ]
  2. Serum DHT Cavg [ Time Frame: 24-hour serial sampling following each of the treatment arms ]
  3. Serum DHT Tmax [ Time Frame: 24-hour serial sampling following each of the treatment arms ]
  4. Serum DHT AUC [ Time Frame: 24-hour serial sampling following each of the treatment arms ]
  5. Serum testosterone undecanoate (TU) Cmax [ Time Frame: 24-hour serial sampling following each of the treatment arms ]
  6. Serum TU Tmax [ Time Frame: 24-hour serial sampling following each of the treatment arms ]
  7. Serum TU AUC [ Time Frame: 24-hour serial sampling following each of the treatment arms ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male
  • Age 18-65
  • Morning serum testosterone (T) <300 ng/dL on two occasions

Exclusion Criteria:

  • Significant intercurrent disease
  • Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score >15 or history of prostate cancer.
  • Serum transaminases >2 times upper limit of normal
  • Serum bilirubin >2.0 mg/dL
  • Hematocrit <35% or >50%
  • BMI >36
  • Untreated, obstructive sleep apnea.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924612


Locations
United States, California
LABiomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Canada, Quebec
Anapharm, Inc.
Quebec City, Quebec, Canada, G1P 0A2
Sponsors and Collaborators
Clarus Therapeutics, Inc.
Investigators
Principal Investigator: Ronald Swerdloff, MD LABiomedical Research Institute at Harbor-UCLA Medical Center

Responsible Party: Robert E. Dudley, PhD, Clarus Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00924612     History of Changes
Other Study ID Numbers: CLAR-09008
First Posted: June 19, 2009    Key Record Dates
Last Update Posted: August 27, 2010
Last Verified: August 2010

Keywords provided by Clarus Therapeutics, Inc.:
Primary hypogonadism
Secondary hypogonadism

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents